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Mylan N.V.'s stock ran up 3.8% in morning trade Tuesday, after Morgan Stanley analyst David Risinger turned bullish on the generic drug maker for the first time, citing greater confidence in growth prospects relative to peers and optimism over its drug pipeline. Risinger raised his rating to overweight, after being at equal weight since starting coverage three years ago, and raised the stock price target to $50 from $39. "Beyond its strong pipeline of new products, Mylan has opportunities to gain share relative to generic competitors which are facing challenges," Risinger wrote in a note to clients. He said the No. 1 market player Teva Pharmaceutical Industries Ltd. is in the process of restructuring and cutting its workforce, the No. 3 player Sandoz's U.S oral generics unit is reportedly up for sale and the No. 8 player Apotex has faced leadership challenges. Mylan's stock has rallied 16.7% over the past three months, while the SPDR S&P Pharmaceuticals ETF has tacked on 1.1% and the S&P 500 has gained 3.6%.

Mylan N.V. said Friday it is planning to launch two new low-cost HIV combination treatments in the U.S. The company said Symfi Lo and Cimduo won U.S. Food and Drug Administration approval in February. Symfi Lo will be introduced in the coming weeks and Cimduo will be launched in the second quarter. The company said it is aiming to address the high cost of HIV treatment, which accounts for more than $20 billion in annual spending and is the category with the highest spend for Medicaid. Mylan is the world's biggest provider of HIV/AIDS therapies, treating more than 40% of the 20 million patients on treatment worldwide. Mylan came under heavy criticism in 2016 for raising the price of the anti-allergy treatment, EpiPen, sixfold. Chief Executive Officer Heather Bresch was forced to defend herself and the company against harsh congressional questioning by a House Oversight Committee. Shares were not yet active premarket, but have fallen 10% in the last 12 months, while the S&P 500 has gained 12%.

Mar. 2, 2018 at 7:43 a.m. ET

by Ciara Linnane

Mylan to introduce 2 new HIV combination treatments in the U.S.

Shares of Mylan NV fell less than 1% late Wednesday after the pharmaceutical company reported better-than-expected adjusted per-share earnings but sales that fell short of expectations. Mylan said it earned $244 million, or 46 cents a share, in the quarter, compared with $418 million, or 78 cents a share, in the year-ago period. Adjusted for one-time items, the company earned $1.43 a share, compared with $1.57 a share a year ago. Revenue fell 1% to $3.24 billion, compared with $3.27 billion in the fourth quarter of 2016. Mylan highlighted an 8% increase in revenue year-over-year in 2017 on "strong performances" in Europe and elsewhere offsetting "ongoing volatility" in the U.S., Mylan said in a statement. Adjusted 2017 EPS fell 7% compared with 2016 "as we absorbed a decline in profitability of approximately $500 million associated with the rebasing of EpiPen," Chief Executive Heather Bresch said in a statement. Mylan expects "a strong financial performance" this year, with revenue of $11.75 billion to $13.25 billion, and adjusted EPS in the range of $5.20 to $5.60, she said. Shares of Mylan ended the regular trading day down 1.9%.

The U.S. Patent Trial and Appeal Board has denied a motion to terminate patent challenges against patents for Allergan's [:s: AGN] dry eye medication Restasis. Allergan previously made a deal with the New York state American Indian tribe the St. Regis Mohawk Tribe to protect Restasis from competition using the tribe's sovereign immunity as a shield against patent challenges, a deal that was widely criticized, including by lawmakers. Generic drugmaker Mylan made the patent challenge against Allergan's Restasis, which targets six patents. Mylan Chief Executive Health Bresch called Allergan's deal with the tribe "a sham." The tribe had not established that its sovereign immunity applied to the specific patent challenge proceedings, the PTAB said, and that even if it did apply, the challenge could continue because Allergan was still involved as an owner of the patents. An oral hearing on the case is tentatively scheduled for April 3, and a final written decision is expected by June 6. A Texas district court judge also previously ruled against Allergan on similar issues last fall. Allergan shares have dropped 6.6% over the last three months and Mylan shares have surged 10.9%, compared with a 5.6% rise in the S&P 500 .

Feb. 26, 2018 at 8:36 a.m. ET

by Emma Court

Final decision by patent board on Allergan's patents expected by early June

Final decision by patent board on Allergan's patents expected by early June

Health care stocks fell in premarket trade Tuesday, setting the sector up for its second consecutive day of declines amid widespread market weakness. The Health Care Select Sector SPDR fell 2.2%, led by a nearly 6% stock drop for Anthem Inc. , a 3.3% decline for Danaher Corp. , a 3.5% decline for Becton, Dickinson and Company and a 3.1% drop for Biogen Inc. . In addition to Anthem, rival health insurer UnitedHealth Group Inc.'s shares dropped 2.4% and Humana Inc.'s shares dropped 1.1%. The SPDR S&P Pharmaceutical ETF was neutral in premarket trade and the SPDR S&P Biotech ETF dropped 2.5%, with drugmaker stocks serving among the more active premarket movers, including a 3% decline for AbbVie Inc. , a 2.6% drop for Sage Therapeutics Inc. , a 2% decline for Vertex Pharmaceuticals Inc. , a 2% drop for Teva Pharmaceutical Industries Ltd. and a 1.6% decline for Mylan NV . One exception to the premarket declines was Allergan PLC , which reported fourth-quarter profit and revenue beats early Tuesday along with positive late-stage clinical trial results for its migraine drug. A 4.4% decline on Monday for the Health Care Select Sector SPDR nearly erased the ETF's year-to-date gains, which now come to 0.44%, compared with a 0.9% decline in the S&P 500 and a 1.5% decline in the Dow Jones Industrial Average .

Five manufacturers of opioid painkillers gave nearly $9 million between 2012 and 2017 to patient advocacy groups and other nonprofits that have a history of promoting opioid use, according to a senator's report.

Mylan N.V.

Mylan N.V., is a pharmaceutical company which engages in the development, license, manufacture, market and distribution of generic, branded generic and specialty pharmaceutical products. The company was founded on July 7, 2014 and is headquartered in Hatfield, United Kingdom.
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